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(amoxapine) Tablets USP
- Patient Information:
Details with Side Effects
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of amoxapine tablets or any other antidepressant in a child, adolescent or young adult must balance this risk with the clinical need. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults aged 65 an older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Amoxapine (amoxapine tablets) is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use)
Amoxapine (amoxapine tablets) is an antidepressant of the dibenzoxazepine class, chemically distinct from the dibenzazepines, dibenzocycloheptenes, and dibenzoxepines. It is designated chemically as 2-Chloro-11-(1-piperazinyl) dibenz [b, f][1,4] oxazepine. The structural formula is represented below:
Amoxapine (amoxapine tablets) is supplied for oral administration as 25 mg, 50 mg, 100 mg and 150 mg tablets. Amoxapine (amoxapine tablets) Tablets USP, 25 mg, 50 mg, 100 mg and 150 mg contain: dibasic calcium phosphate, magnesium stearate, starch (corn), and stearic acid.
Amoxapine (amoxapine tablets) Tablets USP, 50 mg and 150 mg also contain: FD&C Yellow No. 6.
Amoxapine Tablets USP, 100 mg also contain: FD&C Blue No. 2.
What are the possible side effects of amoxapine (Asendin)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have any of these serious side effects:
What are the precautions when taking amoxapine tablets (Amoxapine)?
See also the Warning section.
Before taking amoxapine, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (e.g., amitriptyline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., agranulocytosis, thrombocytopenia), breathing problems (e.g., asthma, COPD), certain eye problems (glaucoma, increased intraocular pressure), intestinal problems (e.g., chronic constipation, ileus), heart problems (e.g., recent heart attack, arrhythmias, coronary artery disease, heart failure), kidney...
Last reviewed on RxList: 7/1/2008
This monograph has been modified to include the generic and brand name in many instances.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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